Surgical fasteners coated with wound treatment materials

ABSTRACT

The present disclosure relates to surgical fasteners and more particularly to surgical fasteners coated with wound treatment materials. According to an aspect of the present disclosure, a surgical fastener for use in combination with a surgical fastener applying apparatus is provided. The surgical fastener includes a pair of legs; a crown interconnecting the pair of legs; and a wound treatment material coating at least a portion of the legs and crown.

CROSS-REFERENCE TO RELATED APPLICATION

This application is a continuation of U.S. application Ser. No.11/250,231, now U.S. Pat. No. 8,097,017, filed Oct. 14, 2005, whichclaims benefit of application No. 60/620,068 filed Oct. 18, 2004, andthe disclosures of each of the above-identified applications are herebyincorporated by reference in their entirety.

BACKGROUND

1. Technical Field

The present disclosure relates to surgical fasteners and moreparticularly to surgical fasteners coated with wound treatmentmaterials.

2. Description of Related Art

Generally, coatings for medical devices are useful to create a waterabsorbent and lubricious coating for surgical instruments, forin-dwelling biomaterials such as stents, screws and internal splints,and for tubing, catheters, wire guides, and the like. Such coatingsminimize the trauma of contact of the medical device with tissues andbiological fluids. In particular, coatings have been used to provide aslippery and lubricious coating for reducing the coefficient of frictionof a surface of a medical device to facilitate movement andmaneuverability of the device. Lubricious coatings made from hydrophilicpolymers are well-known in the art.

Medical devices such as surgical fasteners and staples have replacedsuturing when joining or anastomosing various body structures, such as,for example, the bowel or bronchus. The surgical stapling devicesemployed to apply these staples are generally designed to simultaneouslycut and seal an extended segment of tissue in a patient, thus vastlyreducing the time and risks of such procedures.

Linear or annular surgical stapling devices are employed by surgeons tosequentially or simultaneously apply one or more linear rows of surgicalfasteners, e.g., staples or two-part fasteners, to body tissue for thepurpose of joining segments of body tissue together and/or for thecreation of anastomosis. Linear surgical stapling devices generallyinclude a pair of jaws or finger-like structures between which bodytissue to be joined is placed. When the surgical stapling device isactuated and/or “fired,” firing bars move longitudinally and contactstaple drive members in one of the jaws, and surgical staples are pushedthrough the body tissue and into/against an anvil in the opposite jawthereby crimping the staples closed. A knife blade may be provided tocut between the rows/lines of staples. Examples of such linear surgicalstapling devices are Models “GIA™”, “Endo GIA™” and “Premium Multi-fireTA™” instruments available from United States Surgical, a Division ofTyco Health-Care Group, LP, Norwalk, Conn. and disclosed in, inter alia,U.S. Pat. No. 5,465,896 to Allen et al., U.S. Pat. No. 6,330,965 toMilliman et al., and U.S. Pat. No. 6,817,508 to Racenet et al., theentire contents of each of which are incorporated herein by reference.

Annular surgical stapling devices generally include an annular staplecartridge assembly including a plurality of annular rows of staples,typically two, an anvil assembly operatively associated with the annularcartridge assembly, and an annular blade disposed internal of the rowsof staples.

Another type of surgical stapler is an end-to-end anastomosis stapler.An example of such a device is a Model “EEA™” instrument available fromUnited States Surgical, a Division of Tyco Health-Care Group, LP,Norwalk, Conn. and disclosed in, inter alia, U.S. Pat. No. 5,392,979 toGreen et al., the entire contents of which is incorporated herein byreference. In general, an end-to-end anastomosis stapler typicallyplaces an array of staples into the approximated sections of a patient'sbowels or other tubular organs. The resulting anastomosis contains aninverted section of bowel which contains numerous “B” shaped staples tomaintain a secure connection between the approximated sections of bowel.

In addition to the use of surgical staples, sealants, e.g., biologicalsealants, can be applied to the surgical site to guard against leakage.Typically, the biological sealants are manually applied to the outersurface of the staple line by a physician by spraying on, brushing on,swabbing on, or any combinations thereof. This manual application ofbiological sealant can lead to non-uniformity of the thickness ofsealant across the staple line and/or omitting a portion of the intendedcoverage area due to inability to see or reach the desired location.

A need exists for surgical fasteners and the like for delivering woundtreatment material to a target surgical site without adding additionalsteps or complications to the surgical procedure.

SUMMARY

The present disclosure relates to surgical fasteners and moreparticularly to surgical fasteners coated with wound treatmentmaterials.

According to an aspect of the present disclosure, a surgical fastenerfor use in combination with a surgical fastener applying apparatus isprovided. The surgical fastener includes a pair of legs; a crowninterconnecting the pair of legs; and a wound treatment material coatingat least a portion of the legs and/or crown.

The wound treatment material may be at least one of an adhesive, asealant, a hemostat, and a medicament. In an embodiment, the surgicalfastener is a staple. In another embodiment, the surgical fastener is atwo-part fastener.

The legs and crown of the surgical fastener may be fabricated from atleast one of a non-absorbable and a bio-absorbable material. It isenvisioned that the non-absorbable material is at least one of stainlesssteel and titanium. The bio-absorbable material may be at least one of ahomopolymers, copolymers, and a blend of monomers selected from thegroup consisting of glycolide, glycolic acid, lactide, lactic acid,p-dioxanone, α-caprolactone and trimethylene carbonate. Thebio-absorbable material may also be at least one of Polyglycolic Acid(PGA) and Polylactic Acid (PLA).

The wound treatment material may be a sealant selected from the groupconsisting of acrylate, methacrylate functional hydrogels in thepresence of a biocompatible photoinitiator, alkyl-cyanoacrylates,isocyanate functional macromers with or without amine functionalmacromers, succinimidyl ester functional macromers with amine orsulfhydryl functional macromers, epoxy functional macromers with aminefunctional macromers, mixtures of proteins or polypeptides in thepresence of aldehyde crosslinkers, Genipin, water-soluble carbodiimides,and anionic polysaccharides in the presence of polyvalent cations.

The wound treatment material may also be a sealant selected from thegroup consisting of isocyanate terminated hydrophilic urethaneprepolymers derived from organic polyisocyanates and oxyethylene-baseddiols or polyols; alpha-cyanoacrylate based adhesives; alkyl ester basedcyanoacrylate adhesives; adhesives based on biocompatible cross-linkedpolymers formed from water soluble precursors having electrophilic andnucleophilic groups capable of reacting and cross-linking in situ; twopart adhesive systems including those based upon polyalkylene oxidebackbones substituted with one or more isocyanate groups in combinationwith bioabsorbable diamine compounds, or polyalkylene oxide backbonessubstituted with one or more amine groups in combination withbioabsorbable diisoycanate compounds; and isocyanate terminatedhydrophilic urethane prepolymers derived from aromatic diisocyanates andpolyols.

It is envisioned that the wound treatment material is a hemostatselected from the group consisting of fibrin-based, collagen-based,oxidized regenerated cellulose-based and gelatin-based topicalhemostats.

It is contemplated that the wound treatment material is a medicamentselected from the group consisting of drugs, enzymes, growth factors,peptides, proteins, pigments, dyes, diagnostic agents or hemostasisagents, monoclonal antibodies, or any other pharmaceutical used in theprevention of stenosis.

In an embodiment, the wound treatment material may be impregnated intothe legs and the crown. In another embodiment, the wound treatmentmaterial completely coats the legs and the crown.

It is envisioned that each leg includes a sharpened distal end. It isfurther envisioned that the crown is linear or non-linear.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a perspective view of a surgical fastener in accordance withan embodiment of the present disclosure;

FIG. 2 is a longitudinal cross-sectional view of the surgical fastenerof FIG. 1;

FIG. 3 is a longitudinal cross-sectional view of a surgical fasteneraccording to another embodiment of the present disclosure;

FIG. 4 is a longitudinal cross-sectional view of a surgical fasteneraccording to yet another embodiment of the present disclosure; and

FIG. 5 is a perspective view of an exemplary two-part fastenerconstructed in accordance with the present disclosure.

DETAILED DESCRIPTION OF THE EMBODIMENTS

Embodiments of the presently disclosed surgical fasteners will now bedescribed in detail with reference to the drawing figures wherein likereference numerals identify similar or identical elements. As usedherein and as is traditional, the term “distal” refers to that portionwhich is farthest from the user while the term “proximal” refers to thatportion which is closest to the user.

With reference to FIGS. 1 and 2, a surgical fastener, in the form of asurgical staple, is generally shown as 100. Surgical staples of thepresent disclosure typically include any metallic staple used to jointogether tissue parts and/or adjacent tissues. Surgical staples 100 maybe made of metal, such as, for example, stainless steel or titanium, orany other material known by one having skill in the art. For example,surgical staples 100 may also be fabricated from bio-absorbable materialor the like.

Bio-absorbable materials used for surgical staples 100 include, and arenot limited to, those fabricated from homopolymers, copolymers or blendsobtained from one or more monomers selected from the group consisting ofglycolide, glycolic acid, lactide, lactic acid, p-dioxanone,α-caprolactone and trimethylene carbonate. Other bio-absorbablematerials include and are not limited to, for example, Polyglycolic Acid(PGA) and Polylactic Acid (PLA).

With continued reference to FIGS. 1 and 2, surgical staple 100 includesa pair of legs 102, 104 which are interconnected to one another by acrown or backspan 106 extending between first ends 102 a, 104 a,respectively, thereof. As seen in FIGS. 1 and 2, crown 106 issubstantially perpendicular to legs 102, 104. However, it is envisionedthat crown 106 may take on any shape and/or form as needed and/ordesired and may have any orientation relative to legs 102, 104. Forexample, crown 106 may include two sections which extend angularly fromlegs 102, 104 and are connected at an apex (not shown).

As seen in FIGS. 1 and 2, respective distal ends 102 b, 104 b of legs102, 104 are sharpened to facilitate penetration of legs 102, 104 intotissue or the like.

In accordance with the present disclosure, surgical staple 100 is coatedwith a wound treatment material “W”. It is envisioned that woundtreatment material “W” may be applied to the entirety of surgical staple100 (as seen in FIGS. 1 and 2), or may be applied to any specific areaof surgical staple 100 that is to come into contact with tissue of thelike. For example, wound treatment material “W” may be applied solely tolegs 102, 104 (see FIG. 3); solely to one of legs 102, 104 (not shown);solely to crown 106 (not shown); or any portion thereof. It is furtherenvisioned that wound treatment material “W” may be impregnated intolegs 102, 104 and crown 106 of surgical staple 100, as seen in FIG. 4.

In one embodiment, surgical staples 100 may be fabricated from abio-absorbable material which is desirably impregnated with woundtreatment material “W”. Accordingly, in use, the wound treatmentmaterial component of surgical staples 100 may function to retard anybleeding which may occur from the tissue, in the manner of a sealant,and to secure the approximated tissue together, in the manner of anadhesive. The bio-absorbability of surgical staples 100 allows for theat least a portion of surgical staples 100 to be absorbed into the bodyafter a predetermined amount of time. For example, surgical staples 100may remain in place in the body for approximately 2-3 weeks in order forthe anastomosis to sufficiently heal prior to surgical staples 100 beingabsorbed into the body.

As mentioned above and as shown in FIG. 3, it is envisioned thatsurgical staples 100 may be impregnated with a wound treatment material“W” which is a pre-cured adhesive or sealant. The pre-cured sealant oradhesive will react with the moisture and/or heat of the body tissue tothereby activate the sealing and/or adhesive properties of the sealantor adhesive. It is envisioned that the pre-cured sealant or adhesive maybe a hydro-gel or the like.

It is contemplated that the wound treatment material “W” is any materialfor joining, healing, sealing or otherwise treating tissue. In apreferred embodiment, the wound treatment material is a bio-compatiblesealant, including, and not limited, to sealants which cure upon tissuecontact, sealants which cure upon exposure to ultraviolet (UV) light,sealants which are two-part systems which are kept isolated from oneanother and are combined or any combinations thereof. Any known suitableadhesive may be used. In one embodiment, it is contemplated that suchsealants and/or adhesives are curable. For example, sealants may have acure time of from about 10 to 15 seconds may be used. In preferredembodiments, the sealant and/or adhesive is a bioabsorbable and/orbio-resorbable material. In another embodiment, it is contemplated thata sealant and/or adhesive having a cure time of about 30 seconds may beused. It is further envisioned that wound treatment material “W” may bea pre-cured adhesive or sealant.

In certain preferred embodiments, the wound treatment material “W”comprises a sealant. Such a sealant is desirably a PEG-based material.Examples of classes of materials useful as the sealant and/or adhesiveinclude acrylate or methacrylate functional hydrogels in the presence ofa biocompatible photoinitiator, alkyl-cyanoacrylates, isocyanatefunctional macromers with or without amine functional macromers,succinimidyl ester functional macromers with amine or sulfhydrylfunctional macromers, epoxy functional macromers with amine functionalmacromers, mixtures of proteins or polypeptides in the presence ofaldehyde crosslinkers, Genipin, or water-soluble carbodiimides, anionicpolysaccharides in the presence of polyvalent cations, etc.

Some specific materials which may be utilized include isocyanateterminated hydrophilic urethane prepolymers derived from organicpolyisocyanates and oxyethylene-based diols or polyols, including thosedisclosed in U.S. Pat. Nos. 6,702,731 and 6,296,607 and U.S. PublishedPatent Application No. 2004/0068078; alpha-cyanoacrylate based adhesivesincluding those disclosed in U.S. Pat. No. 6,565,840; alkyl ester basedcyanoacrylate adhesives including those disclosed in U.S. Pat. No.6,620,846; adhesives based on biocompatible cross-linked polymers formedfrom water soluble precursors having electrophilic and nucleophilicgroups capable of reacting and cross-linking in situ, including thosedisclosed in U.S. Pat. No. 6,566,406; two part adhesive systemsincluding those based upon polyalkylene oxide backbones substituted withone or more isocyanate groups in combination with bioabsorbable diaminecompounds, or polyalkylene oxide backbones substituted with one or moreamine groups in combination with bioabsorbable diisoycanate compounds asdisclosed in U.S. Published Patent Application No. 2003/0032734, thecontents of which are incorporated by reference herein; and isocyanateterminated hydrophilic urethane prepolymers derived from aromaticdiisocyanates and polyols as disclosed in U.S. Published PatentApplication No. 2004/0115229, the contents of which are incorporated byreference herein.

It is envisioned and within the scope of the present disclosure thatwound treatment material “W” may include one or a combination ofadhesives, hemostats, sealants, or any other tissue or wound-treatingmaterial. Surgical biocompatible wound treatment materials “W”, whichmay be used in accordance with the present disclosure, include adhesiveswhose function is to attach or hold organs, tissues or structures,sealants to prevent fluid leakage, and hemostats to halt or preventbleeding. Examples of adhesives which can be employed include proteinderived, aldehyde-based adhesive materials, for example, thecommercially available albumin/glutaraldehyde materials sold under thetrade designation BioGlue™ by Cryolife, Inc., and cyanoacrylate-basedmaterials sold under the trade designations Indermil™ and Derma Bond™ byTyco Healthcare Group, LP and Ethicon Endosurgery, Inc., respectively.Examples of sealants, which can be employed, include fibrin sealants andcollagen-based and synthetic polymer-based tissue sealants. Examples ofcommercially available sealants are synthetic polyethylene glycol-based,hydrogel materials sold under the trade designation CoSeal™ by CohesionTechnologies and Baxter International, Inc. Examples of hemostatmaterials, which can be employed, include fibrin-based, collagen-based,oxidized regenerated cellulose-based and gelatin-based topicalhemostats, as well as aluminum alum (i.e., ammonium alum or aluminumammonium sulfate). Examples of commercially available hemostat materialsare fibrinogen-thrombin combination materials sold under the tradedesignations CoStasis™ by Tyco Healthcare Group, LP, and Tisseel™ soldby Baxter International, Inc. Hemostats herein include astringents,e.g., aluminum sulfates, and coagulants. A further example of a hemostatincludes “Quick Clot™”, commercially available from Z-Medica, Inc.,Newington, Conn.

The medicament may include one or more medically and/or surgicallyuseful substances such as drugs, enzymes, growth factors, peptides,proteins, dyes, pigments, diagnostic agents or hemostasis agents,monoclonal antibodies, or any other pharmaceutical used in theprevention of stenosis. The medicament may be disposed on structure 100or impregnated into structure 100.

Wound treatment material “W” may include visco-elastic film formingmaterials, cross-linking reactive agents, and energy curable adhesives.It is envisioned that wound treatment material “W”, and in particular,adhesive may be cured with the application of water and/or glycerin (1,2, 3, -pranatetriol, also known as glycerol or glycerine) thereto. Inthis manner, the water and/or glycerin cure the adhesive and hydrate thewound.

It is further contemplated that wound treatment material “W” mayinclude, for example, compositions and/or compounds which accelerate orbeneficially modify the healing process when particles of thecomposition and/or compound are applied to or exposed to a surgicalrepair site. For example, the wound treatment material “W” may be atherapeutic agent which will be deposited at the repair site. Thetherapeutic agent can be chosen for its antimicrobial properties,capability for promoting repair or reconstruction and/or new tissuegrowth. For example, the wound treatment material “W” may comprise“SilvaSorb™”, commercially available from AcryMed, Inc, Portland, Oreg.Antimicrobial agents such as broad spectrum antibiotic (gentamycinsulfate, erythromycin or derivatized glycopeptides) which are slowlyreleased into the tissue can be applied in this manner to aid incombating clinical and sub-clinical infections in a tissue repair site.To promote repair and/or tissue growth, wound treatment material “W” mayinclude one or several growth promoting factors, e.g., fibroblast growthfactor, bone growth factor, epidermal growth factor, platelet derivedgrowth factor, macrophage derived growth factor, alveolar derived growthfactor, monocyte derived growth factor, magainin, and so forth. Sometherapeutic indications are: glycerol with tissue or kidney plasminogenactivator to cause thrombosis, superoxide dimutase to scavenge tissuedamaging free radicals, tumor necrosis factor for cancer therapy orcolony stimulating factor and interferon, interleukin-2 or otherlymphokine to enhance the immune system.

It is further envisioned and within the of the present disclosure forwound treatment material “W” to include any microbial agent, analgesic,growth factor, and anti-inflammatory agent known by one having skill inthe art or any combination thereof.

Those skilled in the art will recognize that the successful surfacetreatment of surgical staple 100, prior to the application of woundtreatment material “W”, may include pre-cleaning surgical staple 100 andcontrolling the moisture at the surface of surgical staple 100 in orderto ensure complete and/or proper coating of surgical staple 100.Multi-step cleaning and drying operations can therefore be used toprovide a clean surface and to control moisture. Once the surface ofsurgical staple 100 is treated, as described above, a solutioncontaining wound treatment material “W” is applied to the treatedsurgical staple 100.

It is contemplated and within the scope of the present disclosure forany of the surgical staples 100 disclosed herein to be used inconnection with linear-type surgical staplers, non-linear-type surgicalstapler, annular-type surgical staples, endoscopic-type surgicalstaplers, skin-type surgical staplers and the like.

It is further contemplated and within the scope of the presentdisclosure for any of the surgical staples 100 disclosed herein to haveequal length legs, un-equal length legs, a relatively short crown ascompared to the length of the legs, a relatively long crown as comparedto the length of the legs, a symmetrical transverse cross-sectionalprofile in at least one of the legs and the crown, and an asymmetricaltransverse cross-sectional profile in at least one of the legs and thecrown. For example, each leg and/or the crown may have a cross-sectionalprofile which is polygonal, such as, triangular, rectangular, hexagonalany combination thereof or the like. Moreover, each leg and/or the crownmay have a cross-sectional profile which is circular, ovular or thelike. It is further envisioned that the crown may be either linear ofnon-linear.

It is still further contemplated and within the scope of the presentdisclosure for any of the surgical staples 100 disclosed herein toinclude legs which do not lie in the same plane as one another. In otherwords, one leg and the crown of the surgical staple 100 define a firstplane, and the other leg of the surgical staple 100 lies in a secondplane which is non-coplanar, or transverse to the first plane.

As seen in FIG. 5, a surgical fastener, in the form of a two-partfastener, is generally shown as 200. The physical structure of anexemplary surgical fastener 200 is shown and described in U.S. Pat. No.4,534,352, the entire content of which is incorporated herein byreference. Generally, surgical fastener 200 includes a retainer member210 and fastener member 202, which has two prongs or legs 204 that aredriven through tissue (not shown) to engage apertures 212 in retainermember 210. Prongs 204 each include a barb 206 attached to a shank 208.

In accordance with the present disclosure, surgical fastener 200,including retainer member 210 and fastener member 202 may be constructedfrom any of the materials disclosed hereinabove either identically(constructed from the same materials) or uniquely (i.e., constructedfrom different materials) from one another.

It should be understood that various changes in form, detail andapplication of the support structures of the present disclosure may bemade without departing from the spirit and scope of the presentdisclosure.

What is claimed is:
 1. A surgical fastener for use in combination with asurgical fastener applying apparatus, the surgical fastener comprising:a pair of legs; a crown interconnecting the pair of legs; and a woundtreatment material coating a surface of the surgical fastener, the woundtreatment material being a sealant for sealing tissue to minimize fluidleakage and retard tissue bleeding, the sealant being pre-cured on thesurface of the pair of legs prior to delivery to a surgical site by atleast one of exposure to ultra-violet light and combination with anothermaterial.
 2. The surgical fastener according to claim 1, wherein thewound treatment material coats only a surface of the pair of legs. 3.The surgical fastener according to claim 2, wherein the wound treatmentmaterial completely coats the legs.
 4. The surgical fastener accordingto claim 1, wherein the surgical fastener is a staple.
 5. The surgicalfastener according to claim 1, wherein the surgical fastener comprises atwo-part fastener.
 6. The surgical fastener according to claim 1,wherein the legs and crown are fabricated from at least one of anon-absorbable and a bio-absorbable material.
 7. The surgical fasteneraccording to claim 6, wherein the non-absorbable material is at leastone of stainless steel and titanium.
 8. The surgical fastener accordingto claim 1, wherein the wound treatment material includes a sealantselected from the group consisting of acrylate, methacrylate functionalhydrogels in the presence of a biocompatible photoinitiator,alkyl-cyanoacrylates, isocyanate functional macromers with or withoutamine functional macromers, succinimidyl ester functional macromers withamine or sulfhydryl functional macromers, epoxy functional macromerswith amine functional macromers, mixtures of proteins or polypeptides inthe presence of aldehyde crosslinkers, Genipin, water-solublecarbodiimides, and anionic polysaccharides in the presence of polyvalentcations.
 9. The surgical fastener according to claim 1, wherein thewound treatment material includes a sealant selected from the groupconsisting of isocyanate terminated hydrophilic urethane prepolymersderived from organic polyisocyanates and oxyethylene-based diols orpolyols; alpha-cyanoacrylate based adhesives; alkyl ester basedcyanoacrylate adhesives; adhesives based on biocompatible cross-linkedpolymers formed from water soluble precursors having electrophilic andnucleophilic groups capable of reacting and cross-linking in situ; twopart adhesive systems including those based upon polyalkylene oxidebackbones substituted with one or more isocyanate groups in combinationwith bioabsorbable diamine compounds, or polyalkylene oxide backbonessubstituted with one or more amine groups in combination withbioabsorbable diisoycanate compounds; and isocyanate terminatedhydrophilic urethane prepolymers derived from aromatic diisocyanates andpolyols.
 10. The surgical fastener according to claim 1, wherein eachleg includes a sharpened distal end.
 11. The surgical fastener accordingto claim 1, wherein the crown is linear.
 12. A surgical fastener for usein combination with a surgical fastener applying apparatus, the surgicalfastener comprising: a pair of legs; a crown interconnecting the pair oflegs, the legs and crown being fabricated from a bio-absorbablematerial; and a wound treatment material coating a surface of the pairof legs, the wound treatment material being an adhesive that ispre-cured to the pair of legs prior to delivery to a surgical site andthat activates by reacting with tissue moisture.
 13. The surgicalfastener according to claim 12, wherein the surgical fastener is astaple.
 14. The surgical fastener according to claim 12, wherein thesurgical fastener comprises a two-part fastener.
 15. The surgicalfastener according to claim 12, wherein the bio-absorbable material isselected from the group consisting of homopolymers, copolymers, and ablend of monomers selected from the group consisting of glycolide,glycolic acid, lactide, lactic acid, p-dioxanone, .alpha.-caprolactoneand trimethylene carbonate.
 16. The surgical fastener according to claim12, wherein the bio-absorbable material is at least one of PolyglycolicAcid (PGA) and Polylactic Acid (PLA).
 17. The surgical fasteneraccording to claim 12, wherein the wound treatment material completelycoats the legs.
 18. The surgical fastener according to claim 12, whereineach leg includes a sharpened distal end.
 19. The surgical fasteneraccording to claim 12, wherein the crown is linear.
 20. The surgicalfastener according to claim 12, wherein the adhesive cures upon at leastone of an application of water and an application of glycerin.